cGLP Software Systems

In today's world of regulated pharmaceuticals, it's no longer good enough to say you run a laboratory that adheres to best practices; now you must use cGLP software systems to prove it.

There is a set of FDA regulations (21 CFR 58) that must be applied in order for a laboratory to claim Good Laboratory Practice (GLP) compliance. 21 CFR 58 describes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration.

cGLP Software Systems for Laboratories

cGLP software helps a laboratory with document control, organizing and storing the records that allow them to maintain the GLP designation. GLP data records that are stored in cGLP system include:

Name and address of laboratory

Name of the Sponsor

Name of the Study Director

Study title, objective and procedures

List of all control and test articles

Location where raw specimens and data are stored

Description of all methods used

Description of the test system, including frequencies

Description of all dosages, routes of administration and duration

Descriptions of data transformations and calculations useds

cGLP software can also help laboratories with global regulatory requirements to improve quality and ensure compliance. These solutions, include:

Document control/document managementBoth FDA regulations and ISO quality standards require companies to establish a system for document control that is electronic in order to ensure product quality and safety. A document control software system ensures that production processes are all pre-approved, and that changes are restricted to authorized personnel and tracked for future review. Despite the importance of document control and document management in cGLP software, many companies continue to rely on paper-based or partially electronic systems for document control. These systems are plagued by inefficiency and errors that could cause FDA-483 citations or ISO nonconformance.

Corrective action/preventive actionAn organization's corrective action/preventive action (CAPA) process is central to all control points. Corrective actions are intended to determine the cause of nonconformances that have been detected, while preventive actions are the plan put in place to stop the problem from happening again in the future. An automated cGLP system brings great benefits, not only in terms of cost savings but in terms of safety and effectiveness.

Change controlChange control is a process that ensures that changes made to a product are introduced in a controlled manner with a minimal disruption to service. Change control in cGLP software dictates that each proposed change is clearly defined, communicated and approved before it is implemented.

Training managementRegulatory requirements from the FDA and other global regulatory bodies including ISO quality standards mandate companies to execute and document employee training. (21 CFR 211.25 and 820.25). These requirements ensure employees understand how to perform their duties within company and industry guidelines. Well-managed training programs using cGLP software systems with training management components minimize the risk of non-compliance and improve product quality.

Audit management according to cGLP regulationsThe GLP audit process is undoubtedly important but the process can become difficult when auditors rely on paper systems or faulty electronic systems. An auditor can spend days asking for material that laboratory employees will have to hunt in file cabinets strewn through physical locations. cGLP software facilitates this search, greatly decreasing the time required by an audit.

Customer complaintsCustomer complaints in a laboratory situation may indicate serious safety and quality issues. Global regulations and ISO quality standards that require a formal complaint-handling process include, among other things, maintenance of records of complaints of adverse reactions, a thorough investigation of each adverse reaction, and a written report of the investigation (21 CFR Part 606.170). cGLP systems with complaints automation can optimize the complaint handling process and speed up the complaint resolution while meeting government and ISO requirements.

The MasterControl cGLP Software Solution

For compliance to standards of current good laboratory practices, the global regulatory bodies continue to require all core processes and systems within a company to be identified, evaluated, and prioritized. MasterControl's cGLP system allows companies to attain compliance, and all the following, from a trusted professional software company:

Streamline Approval Cycles

Automate Document Distribution

Institute Company-Wide Quality

Accelerate Testing Turnaround

Manage Quality, Solve Problems

MasterControl ensures that all standards to assure cGLP are met and sustained in hundreds of regulated companies worldwide.

MasterControl Can Help Streamline Management of Current Good Laboratory Practices with cGLP Software

MasterControl was the very first content and quality management system provider to offer software applications that directly address the challenges of complying with cGLP and other global quality regulations. The software solutions include integrated, easy-to-use applications that help companies automate the requirements of GLP compliance, such as GLP audit, GLP training, and other requirements.

The QMS Provider for the FDA

MasterControl Inc. and its partner company, i4DM, have been the QMS providers for the FDA’s Office of Regulatory Affairs (ORA) since 2009. The FDA recently expanded its implementation of MasterControl’s Quality Excellence™ solutions to improve the quality and audit management processes of the Division of Pharmaceutical Analysis in the Center for Drug Evaluation and Research (CDER).